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US FDA Advisory Committee votes in favour of maintaining accelerated approval of Roche’s Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer

The Pharma Data

Today’s ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. The FDA has not announced when it will make its final decision for Tecentriq in this indication.

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Pfizer Responds to Research Claims

Pfizer

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., It is important to note that these studies are required by U.S.

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Janssen Presents Results from Phase 3 ACIS

The Pharma Data

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with ERLEADA ® (apalutamide) and ZYTIGA ® (abiraterone acetate) CombinationS. months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001). months; hazard ratio [HR] 0.69 [95% CI, 0.58-0.83]; 0.83]; p<0.0001).

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PFIZER REPORTS STRONG FIRST-QUARTER 2021 RESULTS

The Pharma Data

Raises Full-Year 2021 Guidance (3) for Revenues to a Range of $70.5 Billion and Adjusted Diluted EPS (2) to a Range of $3.55 Now Anticipates Revenues of Approximately $26 Billion for BNT162b2, Reflecting 1.6 Billion Doses Expected to be Delivered in 2021 Under Signed Contracts as of Mid-April 2021. per share amounts). Reported Diluted EPS (1).